AzTrials
AzTrials

Acute Non-cardioembolic Ischemic StrokePhase 2PACIFIC-STROKENCT04304508

Study to Gather Information About Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following a Recent Non Cardioembolic Ischemic Stroke Which Occurs When a Blood Clot Has Formed Somewhere in the Human Body (But Not in the Heart) Travelled to the Brain.

A Phase 2 study testing BAY2433334 in people with Acute Non-cardioembolic Ischemic Stroke, run by Bayer at 197 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give to participants and to look at how well BAY 2433334 works on top of antiplatelet therapy in patients following a recent non cardioembolic ischemic stroke which occurs when a blood clot that has not formed in the heart… Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Acute Non-cardioembolic Ischemic Stroke
What is being tested?
BAY2433334
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,808 participants
Where
197 sitesin 23 countries
Study dates
15 Jun 2020to 18 Feb 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant must be 45 years of age and older at the time of signing the informed consent
  • Non-cardioembolic ischemic stroke with
  • persistent signs and symptoms of stroke lasting for ≥ 24 hours OR
  • acute brain infarction documented by computed tomography (CT) or MRI AND
  • with the intention to be treated with antiplatelet therapy during the study conduct
  • Imaging of brain (CT or MRI) ruling out hemorrhagic stroke or another pathology that could explain symptoms (e.g. brain tumor, abscess, vascular malformation)
Show all 11Show fewer
  • Severity of index event nearest the time of randomization:
  • Part A: minor stroke (defined as National Institutes of Health Stroke Scale (NIHSS) ≤ 7) can be enrolled
  • Part B: participants with minor or moderate stroke and NIHSS ≤ 15 can be enrolled. Participants undergoing thrombolysis or endovascular therapy (mechanical thrombectomy) can be enrolled but at the earliest 24 hours after the intervention
  • Randomization within 48 hours after the onset of symptoms of the index event (or after patients were last known to be without symptoms in case of wake-up stroke)
  • Ability to conduct an MRI either before randomization or within 72 hours after randomization

Who cannot join

  • Prior ischemic stroke within last 30 days of index event
  • History of atrial fibrillation or suspicion of cardioembolic source of stroke
  • Dysphagia with inability to safely swallow study medication
  • Contraindication to perform brain MRI
  • Part A only: thrombolysis or endovascular therapy (mechanical thrombectomy) performed for index event
  • Active bleeding; known bleeding disorder, history of major bleeding (intracranial, retroperitoneal, intraocular) or clinically significant gastrointestinal bleeding within last 6 months of randomization.

Trial locations and contacts

197 sites in 23 countries.

197 sites in 23 countries

Japan22 sites

  • Nozaki Tokushukai Hospital

    Daitō, Osaka, 574-0074

  • Saiseikai Fukuoka General Hospital

    Fukuoka, 810-0001

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, 810-8563

  • Gifu Prefectural General Medical Center

    Gifu, 500-8717

  • Hakodate Shintoshi Hospital

    Hakodate, Hokkaido, 041-0802

  • Hyogo Prefectural Harima-Himeji General Medical Center

    Himeji, Hyōgo, 670-8560

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, 730-8518

  • Shonan Kamakura General Hospital

    Kamakura, Kanagawa, 247-8533

  • Kokura Memorial Hospital

    Kitakyushu, Fukuoka, 802-8555

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

  • Chikamori Hospital

    Kochi, 780-8522

  • Southern Tohoku Medical Clinic

    Kōriyama, Fukushima, 963-8563

  • Saiseikai Kumamoto Hospital

    Kumamoto, 861-4193

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto, 861-8520

  • St.Mary's Hospital

    Kurume, Fukuoka, 830-8543

  • Kyoto Okamoto Memorial Hospital

    Kusegun, Kyoto, 613-0034

  • Ijinkai Takeda General Hospital

    Kyoto, 601-1495

  • Kyorin University Hospital

    Mitaka, Tokyo, 181-8611

  • Nagano Municipal Hospital

    Nagano, 381-8551

  • Nagoya Ekisaikai Hospital

    Nagoya, Aichi-ken, 454-8502

  • JA Toride Medical Center

    Toride, Ibaraki, 302-0022

  • Uji-Tokushukai Medical Center

    Uji, Kyoto, 611-0041

Other trials in Japan

Spain15 sites

  • Complejo Hospitalario Universitario de Albacete | Hospital General Universitario - Neurology Department, Stroke Unit

    Albacete, 02006

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital del Mar

    Barcelona, 08003

  • Ciutat Sanitaria i Universitaria de la Vall d'Hebron

    Barcelona, 08023

  • Hospital de la Santa Creu i Sant Pau | Neurology Department - Stroke, No-Cardioembolic-Tia

    Barcelona, 08025

  • Hospital Universitario Arnau de Vilanova de Lleida

    Lleida, 25198

  • Hospital Universitario de la Princesa

    Madrid, 28006

  • Hospital Universitario Ramon y Cajal | Neurology Department - Stroke, No-Cardioembolic-Tia

    Madrid, 28034

  • Hospital Clinico Universitario San Carlos | Neurologia

    Madrid, 28040

  • Hospital Rey Juan Carlos

    Móstoles, Madrid, 28933

  • Hospital Clínico Universitario de Santiago de Compostela

    Santiago de Compostela, A Coruña, 15706

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

  • Hospital de la Mútua de Terrassa

    Terrassa, Barcelona, 8221

  • La Fe University and Polytechnic Hospital | Neurology Service - Vascular Unit

    Valencia, 46026

  • Hospital Universitario Clinico de Valladolid | Neurology Department

    Valladolid, 47003

Other trials in Spain

Australia11 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Grampians Health Ballarat

    Ballarat, Victoria, 3350

  • Sunshine Coast University Hospital

    Birtinya, Queensland, 4575

  • Eastern Clinical Research Unit - Box Hill

    Box Hill, Victoria, 3128

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6961

  • John Hunter Hospital

    New Lambton, New South Wales, 2305

  • Royal Melbourne Hospital

    Parkville, Victoria, 3052

  • The Alfred Hospital

    Prahran, Victoria, 3004

  • Gold Coast University Hospital

    Southport, Queensland, 4215

  • Royal North Shore Hospital

    Sydney, New South Wales, 2065

Other trials in Australia

France11 sites

  • Hopital Jean Minjoz

    Besançon, 25030

  • Hôpital Pellegrin - Bordeaux

    Bordeaux, 33000

  • Centre Hospitalier Universitaire - Le Kremlin Bicêtre

    Le Kremlin-Bicêtre, 94275

  • Centre Hospitalier - Le Mans

    Le Mans, 72037

  • Hôpital B - Lille

    Lille, 59037

  • Hopital Central - Nancy

    Nancy, 54037

  • Hôpital Lariboisière - Paris

    Paris, 75475

  • Hôpital de la Pitié-Salpétrière

    Paris, 75634

  • Centre hospitalier Sainte Anne

    Paris, 75674

  • Hôpital Pontchaillou

    Rennes, 35033

  • Hôpital Purpan - Toulouse

    Toulouse, 31059

Other trials in France

Germany11 sites

  • Klinikum Altenburger Land GmbH

    Altenburg, Thuringia, 04600

  • Rhön-Klinikum Campus Bad Neustadt

    Bad Neustadt an der Saale, Bavaria, 97616

  • Heinrich-Heine-Universität Düsseldorf

    Düsseldorf, North Rhine-Westphalia, 40225

  • Alfried Krupp Krankenhaus Rüttenscheid /Neurologie

    Essen, North Rhine-Westphalia, 45131

  • Universitätsklinikum der Johann Wolfgang Goethe Universität

    Frankfurt am Main, Hesse, 60528

  • Klinikum Frankfurt Höchst GmbH

    Frankfurt am Main, Hesse, 65929

  • Medizinische Hochschule Hannover (MHH)

    Hanover, Lower Saxony, 30625

  • Universitätsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

  • Universitätsklinikum Leipzig AöR

    Leipzig, Saxony, 04103

  • Eberhard-Karls-Universität Tübingen

    Tübingen, Baden-Wurttemberg, 72076

  • Universitätsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Bulgaria10 sites

  • MHAT Haskovo

    Haskovo, 6300

  • UMHAT Dr. Georgi Stranski

    Pleven, 5809

  • MHAT Sveti Pantaleymon - Plovdiv

    Plovdiv, 4000

  • UMHAT Kanev AD

    Rousse, 7002

  • First Multiprofile Hospital for Active Treatment Sofia EAD

    Sofia, 1000

  • MHAT National Cardiology Hospital EAD

    Sofia, 1309

  • Acibadem City Clinic Multiprofile Hospital for Active Treatm

    Sofia, 1407

  • UMHATEM N. I. Pirogov EAD

    Sofia, 1606

  • UMHAT "Sveta Anna"-Sofia

    Sofia, 1750

  • MHAT Sveta Marina EAD

    Varna, 9010

Other trials in Bulgaria

Czechia9 sites

  • Fakultni nemocnice u sv. Anny

    Brno, 656 91

  • Nemocnice Ceske Budejovice, a.s. Department of kardiologie

    České Budějovice, 370 01

  • Fakultni Nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Hospital Jihlava - Nemocnice Jihlava

    Jihlava, 58633

  • Vitkovicka nemocnice a.s.

    Ostrava Vitkovice, 70384

  • Fakultni nemocnice Ostrava

    Ostrava-Poruba, 708 52

  • Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice

    Pardubice, 530 03

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 10034

  • Nemocnice na Homolce - Neurology Department

    Praha 5-Motol, 150 00

Other trials in Czechia

Italy9 sites

  • A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi"

    Ancona, The Marches, 60126

  • AUSL di Bologna

    Bologna, Emilia-Romagna, 40133

  • AUSL della Romagna

    Forlì Cesena, Emilia-Romagna, 47521

  • Ospedale San Raffaele s.r.l.

    Milan, Lombardy, 20132

  • Fondazione Istituto Neurologico Nazionale Casimiro Mondino

    Pavia, Lombardy, 27100

  • A.O. di Perugia

    Perugia, Umbria, 06129

  • AUSL-IRCCS di Reggio Emilia

    Reggio Emilia, Emilia-Romagna, 42123

  • A.O. San Camillo-Forlanini

    Rome, Lazio, 00152

  • A.O.U. Senese

    Siena, Tuscany, 53100

Other trials in Italy

Slovakia9 sites

  • Univerzitna nemocnica Bratislava, Nemocnica Stare Mesto

    Bratislava, 813 69

  • Dolnooravska nemocnica s poliklinikou L. Nadasi Jegeho

    Dolný Kubín, 026 14

  • Vseobecna nemocnica s poliklinikou Levoca, a.s.

    Levoča, 054 01

  • Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu

    Liptovský Mikuláš, 031 023

  • Svet zdravia, a. s. Vseobecna nemocnica Rimavska Sobota

    Rimavská Sobota, 979 12

  • Fakultna nemocnica AGEL Skalica, a.s.

    Skalica, 909 82

  • Svet zdravia, a.s. Nemocnica s poliklinikou Spisska Nova Ves

    Spišská Nová Ves, 05201

  • Fakultna nemocnica Trnava

    Trnava, 917 75

  • Vseobecna nemocnica v Ziari nad Hronom

    Žiar nad Hronom, 965 37

Other trials in Slovakia

United Kingdom9 sites

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ

  • Countess of Chester Hospital

    Chester, Cheshire, CH2 1UL

  • University Hospitals Coventry and Warwickshire NHS Trust

    Coventry, CV2 2DX

  • Glasgow Royal Infirmary | Glasgow Clinical Research Facility

    Glasgow, G4 0SF

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF

  • St George's Hospital

    London, SW17 0QT

  • Charing Cross Hospital

    London, W6 8RF

  • Arrowe Park Hospital

    Metropolitan Borough of Wirral, Merseyside, CH49 5PE

  • Royal Victoria Infirmary

    Newcastle upon Tyne, Tyne and Wear, NE1 4LP

Other trials in United Kingdom

Belgium8 sites

  • AZ Klina / Neurology

    Brasschaat, 2930

  • UZ Brussel

    Brussels, 1090

  • Jessa Ziekenhuis

    Hasselt, Limburg, 3500

  • UZ Leuven Gasthuisberg

    Leuven, 3000

  • CHC MontLégia

    Liège, Liège, 4000

  • Kust, Ommeland en Meetjesland (KOM) Network | AZ Damiaan - Neurology Department

    Ostend, 8400

  • AZ Delta / Neurology

    Roeselare, 8800

  • Clinique de l'Europe

    Uccle, 1180

Other trials in Belgium

China8 sites

  • Baogang hospital

    Baotou, Inner Mongolia, 014010

  • The First Hospital of Jilin University

    Changchun, Jilin, 130000

  • Daqing Oilfield General Hospital

    Daqing, Heilongjiang, 163000

  • People's Hospital of Deyang City

    Deyang, Sichuan, 618099

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210006

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, 210009

  • Huashan Hospital, Fudan University

    Shanghai, 200040

  • Tianjin Huanhu Hospital

    Tianjin, 300350

Other trials in China

Denmark8 sites

  • Aalborg Universitetshospital -Neurology

    Aalborg, 9100

  • Aarhus Universitetshospital, Skejby

    Aarhus N, 8200

  • Bispebjerg Hospital

    Copenhagen, 2400

  • Rigshospitalet Glostrup

    Glostrup Municipality, 2600

  • Herlev Hospital - Neurology Dept.

    Herlev, 2730

  • Regionshospitalet Gødstrup

    Herning, 7400

  • Nordsjælland Hospital Hillerød

    Hillerød, DK-3400

  • Sygehus Lillebaelt | Kolding Sygehus - Medicinske Sygdomme

    Kolding, 6000

Other trials in Denmark

Portugal8 sites

  • Hospital Garcia de Orta | Research Department

    Almada, Setúbal District, 2801-951

  • CHUC - Hospitais da U. Coimbra - Servico de Neurologia

    Coimbra, 3004-561

  • CHLO - Hospital Egas Moniz

    Lisbon, 1349-019

  • Hospital da Luz - Lisboa

    Lisbon, 1500-650

  • CHULN - Hospital Santa Maria

    Lisbon, 1649-035

  • Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica

    Loures, Lisbon District, 2674-514

  • ULSM - Hospital Pedro Hispano

    Matosinhos Municipality, Porto District, 4464-513

  • CHUSJ - Hospital Sao Joao

    Porto, 4200-319

Other trials in Portugal

Russia8 sites

  • City Clinical Hospital #3

    Chelyabinsk, 454021

  • Sci-Res. Institute of Complex Cardiovascular Disorders

    Kemerovo, 650002

  • Regional Clinical Hospital #1 n.a. prof. S.V. Ochapovsky

    Krasnodar, 350086

  • Railway clinical hospital on the station Novosibirsk-Glavniy

    Novosibirsk, 630003

  • City clinical hospital #40 Sestroretsk

    Sestroretsk, 197706

  • Tomsk Regional Clinical Hospital

    Tomsk, 634063

  • Clinical Inter-District Hospital of Vsevolozhsk

    Vsevolozhsk, 188643

  • Sverdlovsk Regional Clinical Hospital #1

    Yekaterinburg, 620102

Other trials in Russia

Austria7 sites

  • Krankenhaus der Barmherzigen Brüder Eisenstadt

    Eisenstadt, Burgenland, 7000

  • Medizinische Universität Innsbruck

    Innsbruck, Tyrol, 6020

  • Konventhospital Barmherzige Brüder Linz

    Linz, Upper Austria, 4021

  • Christian-Doppler-Klinik

    Salzburg, 5020

  • Krankenhaus der Barmherzigen Brüder

    Vienna, 1020

  • Universitätsklinikum AKH Wien

    Vienna, 1090

  • Klinik Favoriten - Sozialmedizinisches Zentrum Süd

    Vienna, 1100

Other trials in Austria

Poland7 sites

  • Copernicus PL, M.Kopernik Hospital

    Gdansk, 80-803

  • Samodzielny Publiczny Specjalistyczny Szpital Zachodni

    Grodzisk Mazowiecki, 05-825

  • Gornoslaskie CM im. Prof. Leszka Gieca SUM w Katowicach

    Katowice, 40-635

  • Szpital Uniwersytecki w Krakowie

    Krakow, 30-688

  • Samodzielny Publiczny Szpital Kliniczny nr 4

    Lublin, 20-090

  • Mazowiecki Szpital Specjalistyczny im. dr. Jozefa Psarskiego

    Ostrołęka, 07-410

  • Wojskowy Instytut Medyczny

    Warsaw, 04-141

Other trials in Poland

Hungary6 sites

  • Eszak-Pesti Centrumkorhaz-Honvedkorhaz

    Budapest, 1134

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Flor Ferenc Korhaz

    Kistarcsa, 2143

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs, 7624

  • SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont

    Szeged, 6725

  • Zala Megyei Szent Rafael Korhaz

    Zalaegerszeg, 8900

Other trials in Hungary

Switzerland6 sites

  • Kantonsspital Baden

    Baden, 5404

  • Universitätsspital Basel

    Basel, Canton of Basel-City, 4031

  • Inselspital Universitätsspital Bern

    Bern, 3010

  • Spitalzentrum Biel

    Biel/Bienne, Canton of Bern, 2501

  • Ospedale regionale di Lugano

    Lugano, 6900

  • Kantonsspital St. Gallen

    Sankt Gallen, Canton of St. Gallen, 9007

Other trials in Switzerland

United States5 sites

  • University of Pittsburgh Medical Center Hamot

    Erie, Pennsylvania, 16550

  • Minneapolis Clinic of Neurology, Ltd.

    Golden Valley, Minnesota, 55422

  • Guilford Neurologic Associates

    Greensboro, North Carolina, 27405

  • St. Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Univ.of South Florida College of Medicine

    Tampa, Florida, 33606

Other trials in United States

Netherlands4 sites

  • Academisch Medisch Centrum (AMC)

    Amsterdam, 1105 AZ

  • Zuyderland Medisch Centrum

    Heerlen, 6419 PC

  • St. Antonius Ziekenhuis

    Nieuwegein, 3435 CM

  • Isala

    Zwolle, 8025 AB

Other trials in Netherlands

Finland3 sites

  • HUS, Meilahden sairaala

    Helsinki, 00029

  • Itä-Suomen yliopisto

    Kuopio, 70210

  • Turun yliopistollinen keskussairaala

    Turku, FIN-20520

Other trials in Finland

Sweden3 sites

  • Skånes Universitetssjukhus

    Lund, 221 85

  • Danderyds sjukhus

    Stockholm, 182 88

  • Norrlands Universitetssjukhus, Umeå

    Umeå, 901 85

Other trials in Sweden

About this study

Official title: Multicenter, Randomized, Placebo-controlled, Double-blind, Parallel Group, Dose-finding Phase 2 Study to Evaluate Efficacy and Safety of BAY2433334 in Patients Following an Acute Non-cardioembolic Ischemic Stroke

The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give to participants and to look at how well BAY 2433334 works on top of antiplatelet therapy in patients following a recent non cardioembolic ischemic stroke which occurs when a blood clot that has not formed in the heart travelled to the brain. BAY 2433334, works by blocking a step of the blood clotting process in our body and thins the blood and is a so called oral FXIa inhibitor.

Being tested
BAY2433334, BAY2433334 matching placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAY2433334Drug

    Tablet, taken orally once a day.

  • BAY2433334 matching placeboOther

    Tablet, taken orally once a day.

Study groups in NCT04304508
Study groupRoleWhat they receive
BAY2433334 high doseExperimentalNot described
Receives: Drug: BAY2433334
BAY2433334 medium doseExperimentalNot described
Receives: Drug: BAY2433334
BAY2433334 low doseExperimentalNot described
Receives: Drug: BAY2433334
BAY2433334 matching placeboPlacebo comparatorNot described
Receives: Other: BAY2433334 matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy-Number of Participants With Composite of Symptomatic Ischemic Stroke or Covert Brain Infarcts Detected by Magnetic Resonance Imaging (MRI)

    Ischemic stroke was defined as either of : 1) Rapid onset (or present on awakening) of a new focal neurological deficit with clinical (>24 hours symptoms/signs) or imaging evidence of infarction that was not attributable to a non-ischemic cause; 2) Acute worsening of an existing focal neurological deficit that was judged to be attributable to a new infarction or extension of the previous infarction in the same vascular territory, based on persisting symptoms/signs or imaging evidence of infarction and no evidence of a non-ischemic etiology. If imaging was inconclusive, persistent symptoms/signs must be significant (worsening of NIHSS score of 4 or more) and sustained (duration of ≥24 hours or until death). Covert brain infarcts were defined as incident infarcts detected by serial MRI in the absence of an adjudicated stroke consistent with the location of the infarct. MRI criteria for brain infarction were available in the MRI procedures manual.

    Measured: From baseline up to 26 weeks

  2. Safety-Number of Participants With Composite of International Society on Thrombosis and Hemostasis (ISTH) Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding

    ISTH Major Bleeding criteria: 1. Fatal bleeding, and/or 2. Symptomatic bleeding in a critical area or organ (intracranial, intraocular, intraspinal, pericardial, retroperitoneal, intraarticular, or intramuscular with compartment syndrome), and/or 3. Clinically overt bleeding associated with a recent decrease in the hemoglobin level of ≥ 2 g/dL (20 g/L; 1.24 mmol/L) compared to the most recent hemoglobin value available before the event, and/or 4. Clinically overt bleeding leading to transfusion of 2 or more units of packed red blood cells or whole blood. ISTH Clinically Relevant Non-Major Bleeding is considered any sign or symptom of hemorrhage that does not fit the criteria for the ISTH definition of major bleeding, but does meet at least one of the following criteria 1. requiring medical intervention by a healthcare professional. 2. leading to hospitalization or increased level of care. 3. prompting a face to face (i.e. not just a telephone or electronic communication) evaluation.

    Measured: From baseline up to 52 weeks

Secondary outcomes (12)

  1. Efficacy-Number of Participants With Composite of Symptomatic Ischemic Stroke and Covert Brain Infarcts Detected by MRI, Cardiovascular (CV) Death, Myocardial Infarction (MI) and Systemic Embolism.

    CV death included death due to stroke, MI, heart failure or cardiogenic shock, sudden death or any other death due to other cardiovascular causes. Death due to non-traumatic hemorrhage was included. Acute MI was used when there was evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia. According to MI Universal Definition from 2018 the diagnosis of MI required the combination of: 1) Presence of acute myocardial injury, and 2) Evidence of acute myocardial ischemia derived from the clinical presentation, electrocardiographic changes, or the results of myocardial or coronary artery imaging, or in case of post-mortem pathological findings irrespective of biomarker values. Systemic embolism was defined as abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms (this did not include thromboembolism of the pulmonary vasculature or venous thrombosis).

    Measured: From baseline up to 26 weeks

  2. Efficacy-Number of Participants With Symptomatic Ischemic Stroke

    Definition of symptomatic ischemic stroke can be referred to first Primary endpoint.

    Measured: From baseline up to 52 weeks

  3. Efficacy-Number of Participants With Covert Brain Infarcts Detected by MRI

    Definition of covert brain infarcts can be referred to first Primary endpoint.

    Measured: From baseline up to 26 weeks

  4. Efficacy-Number of Participants With Symptomatic Ischemic Stroke, CV Death, MI

    Definition of symptomatic ischemic stroke can be referred to first Primary endpoint. Definition of CV death and MI can be referred to first Second endpoint.

    Measured: From baseline up to 52 weeks

  5. Efficacy-Number of Participants With Symptomatic Ischemic and Hemorrhagic Stroke

    Definition of symptomatic ischemic can be referred to fourth secondary endpoint. Hemorrhagic stroke was defined as an acute, atraumatic extravasation of blood into the brain parenchyma, intraventricular or subarachnoid space with associated neurological symptoms. This did not include microbleeds or hemorrhagic transformation of an ischemic stroke.

    Measured: From baseline up to 52 weeks

  6. Efficacy-Number of Participants With Disabling Stroke (mRS≥4)

    Modified ranking score (mRS): 0-No symptoms at all; 1-No significant disability despite symptoms; despite symptoms, able to carry out all usual duties and activities; 2-Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance; 3-Moderate disability; requiring some help, but able to walk without assistance; 4-Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5-Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6-Death.

    Measured: From baseline up to 52 weeks

  7. Efficacy-Number of Participants With All-cause Mortality

    Measured: From baseline up to 52 weeks

  8. Safety-Number of Participants With All Bleeding

    All bleeding events occurred from first intake of study intervention until 2 days after the last intake of study intervention.

    Measured: From baseline up to 52 weeks

  9. Safety-Number of Participants With ISTH Major Bleeding

    Definition of ISTH major bleeding can be referred to second Primary endpoint.

    Measured: From baseline up to 52 weeks

  10. Safety-Number of Participants With ISTH CRNM Bleeding

    Definition of ISTH CRNM bleeding can be referred to second Primary endpoint.

    Measured: From baseline up to 52 weeks

  11. Safety-Number of Participants With ISTH Minor Bleeding

    All other overt bleeding episodes not meeting the above criteria for ISTH major or CRNM bleeding were classified as minor bleeding (e.g. bleeding from a minor wound that does not prompt a face-to-face evaluation for a physical examination or laboratory testing).

    Measured: From baseline up to 52 weeks

  12. Safety-Number of Participants With Intracerebral Hemorrhage (Non-traumatic)

    Non-traumatic intracerebral hemorrhage was defined as a hemorrhagic stroke on the "recurrent stroke" CRF page that is in addition classified as a bleeding with bleeding site intracranial (-subarachnoid, -intraparenchymal [excluding microbleeds], or -intraventricular) and spontaneous causality of bleeding, excluding all symptomatic and hemorrhagic transformation (defined by the PT "hemorrhagic transformation").

    Measured: From baseline up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2020
  2. Study start15 Jun 2020
  3. Primary completion18 Feb 2022
  4. Study completion18 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,808 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04304508
Sponsor's protocol ID
19766
Other IDs
2019-003431-33, 2019
Acronym
PACIFIC-STROKE
Status last verified
Apr 2023
First submitted
8 Mar 2020
Last updated
19 Apr 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Publications

  • Hart RG, Smith EE, Wang A, Mundl H, Colorado P, Joundi RA, Katsanos AH, Sharma M, Shoamanesh A. Location, size, and risk factors of incident covert brain infarcts in patients with acute non-cardioembolic ischemic stroke: PACIFIC-STROKE trial. Eur Stroke J. 2025 Dec;10(4):1413-1420. doi: 10.1177/23969873251344485. Epub 2025 Jun 13.

    PubMed 40515384

  • Smith EE, Shoamanesh A, Xu L, Heenan L, Saad F, Colorado P, Chen CH, Lemmens R, De Marchis GM, Caso V, Masjuan J, Hirano T, Milanov I, Campbell BCV, Mas JL, Connolly SJ, Mundl H, Hart RG; PACIFIC-Stroke Steering Committee and Investigators. Effect of the Factor XIa Inhibitor Asundexian According to Baseline Infarct Pattern and on MRI Covert Infarct Outcomes. Stroke. 2024 Feb;55(2):392-402. doi: 10.1161/STROKEAHA.123.043198. Epub 2024 Jan 4.

    PubMed 38174569

  • Whiteson HZ, Frishman WH. Factor XI/XIa Inhibitors: A New Approach to Anticoagulation. Cardiol Rev. 2025 Jul-Aug 01;33(4):306-311. doi: 10.1097/CRD.0000000000000624. Epub 2023 Dec 1.

    PubMed 38038437

  • Balali P, Hart RG, Smith EE, Saad F, Colorado P, Lemmens R, De Marchis GM, Caso V, Xu L, Heenan L, Connolly SJ, Mundl H, Shoamanesh A. Cerebral microbleeds and asundexian in non-cardioembolic ischemic stroke: Secondary analyses of the PACIFIC-STROKE randomized trial. Int J Stroke. 2024 Jun;19(5):526-535. doi: 10.1177/17474930231216339. Epub 2023 Dec 16.

    PubMed 37950392

  • Shoamanesh A, Mundl H, Smith EE, Masjuan J, Milanov I, Hirano T, Agafina A, Campbell B, Caso V, Mas JL, Dong Q, Turcani P, Christensen H, Ferro JM, Veltkamp R, Mikulik R, De Marchis GM, Robinson T, Lemmens R, Stepien A, Greisenegger S, Roine R, Csiba L, Khatri P, Coutinho J, Lindgren AG, Demchuk AM, Colorado P, Kirsch B, Neumann C, Heenan L, Xu L, Connolly SJ, Hart RG; PACIFIC-Stroke Investigators. Factor XIa inhibition with asundexian after acute non-cardioembolic ischaemic stroke (PACIFIC-Stroke): an international, randomised, double-blind, placebo-controlled, phase 2b trial. Lancet. 2022 Sep 24;400(10357):997-1007. doi: 10.1016/S0140-6736(22)01588-4. Epub 2022 Sep 2.

    PubMed 36063821

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BAY2433334 in people with Acute Non-cardioembolic Ischemic Stroke, run by Bayer at 197 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 197 sites in Japan, Spain, Australia, France, Germany and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy-Number of Participants With Composite of Symptomatic Ischemic Stroke or Covert Brain Infarcts Detected by Magnetic Resonance Imaging (MRI) (time frame: From baseline up to 26 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04304508, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.

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